The US Department of Justice (DOJ) is getting closer to wrapping up its two-year long investigation into claims for implantable cardioverter defibrillators (ICDs), according to press reports. Hospitals around the country reportedly received e-mails on Aug. 30 asking them to conduct self-audits of their ICD cases and providing them with a model for resolution of the investigation. Questionable cases will be evaluated on an individual basis and the penalties levied against each of the hospitals will vary, based on the severity of harm, prior knowledge of wrongdoing, existence of a compliance program and other such factors.

The DOJ launched its investigation to ensure hospitals are adhering to Medicare’s National Coverage Determination (NCD) on ICDs.  While some physicians have expressed concern that the NCD is outdated, the DOJ emphasized that the rules determined in 2005 are still in place. The DOJ also stressed that while procedures will be scrutinized, not every case that deviates from the NCD will be penalized.

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